Events

Rappel de RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Thermo Fisher Scientific Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00063-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-25
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00063-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Iris international (the manufacturer) has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the rt12 rotor and shield. a shield was implemented on similar models and this notification is to inform ssmp users that the shield must be used when operating the centrifuge. there have been no reports of the statspin mp centrifuge failing to contain debris when users operate statspin mp centrifuges according to the statspin mp operator’s manual (doc # 55-001806-001) and rt12 tube rotor instructions (doc # 54-006155-001).
  • Action
    ThermoFisher is providing additional maintainance instructions and updated operators manual. The information included is intended to supplement the current SSMP Operator Manual.

Device

RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)
  • Modèle / numéro de série
    RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)RT12 Tube Rotor-Kit (RT12) Catalogue Number: RT12-KIT (REF x00-006152-001), Product Labeling: 54-006155-001StatSpin MP Centrifuge Catalogue Number: SSMP (REF x00-004998-001), Product Labeling: 55-001806-001HAll Serial Numbers
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd